Re-imagining Hip and Knee Arthroplasty Wait-list in Nova Scotia: Pre-surgery Support Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Recruitment rate
研究概览
简要总结
This project will outline a pre-surgery support program that identifies risk factors related to poor surgical outcomes and recommends actions to improve these before surgery.
The main questions this study attempts to answer are:
- Is a formalized knee-hip pre-surgery support program feasible, measured by recruitment rate, adherence, and completion rate?
- Does the support program improve surgical risk factors including hemoglobin A1c (HB A1C), blood pressure, hemoglobin, estimated glomerular filtration rate (eGFR), frailty score, and physical fitness and function (measured with the 2-minute step test and 30s second sit to stand test)?
Participants will participate in education, medical navigation, and exercise.
详细描述
Study Design
This is a non-randomized pragmatic pilot intervention study.
Participants
Up to 100 people will participate in this pilot study. A minimum of 30 participants is required, 20 in the exercise group and 5 in each control group. This would give the investigators enough data to assess the feasibility of the exercise class as well as to develop means and standard deviations (SDs) of change that could inform a power calculation for a controlled trial.
Recruitment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On surgery wait list for total hip or knee arthroplasty at Valley Regional Hospital
- •18+ and able to provide informed consent
- •Anticipated surgery time 8-16 weeks after the study start date
排除标准
- •Any contraindications or exclusions identified through the assessment process that are outside thresholds for acceptable surgery risk
结局指标
主要结局
Recruitment rate
时间窗: Study baseline
the number of consenting participants divided by the total number of participants asked to join the study
Adherence to enhanced support program
时间窗: Pre-surgery (10-16 weeks after baseline)
percent of planned sessions attended
Recruitment rate for enhanced support
时间窗: Study baseline
the number of consented and screened participants signing up to the support program, divided by the total number of participants recommended to the support program
Completion rate
时间窗: Pre-surgery (10-16 weeks after baseline)
number of participants that completed the study divided by the number of participants that started the study
次要结局
- Condition specific health-related quality of life(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery))
- Generic health-related quality of life(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery))
- Health behaviours(Study baseline and pre-surgery (10-16 weeks after baseline))
- Physical activity level(Study baseline and pre-surgery (10-16 weeks after baseline))
- Physical function(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline), post-surgery (approx. 6 weeks after surgery))
- Physical fitness(Study baseline and pre-surgery (10-16 weeks after baseline))
- Hemoglobin A1c(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))
- estimated glomerular filtration rate(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))
- Hemoglobin(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))
- Frailty(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))
- Body mass index(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))
- Program satisfaction(Pre-surgery (10-16 weeks after baseline))
- Blood pressure (systolic and diastolic)(Initial assessment (approx. 6-12 months before study enrolment), study baseline, pre-surgery (10-16 weeks after baseline))